1. Field of the Invention
The present invention relates to the intravenous administration of liquid nutrients and/or medicants to a patient. More particularly, the present invention relates to the administration of single or multiple nutrients and/or medicants to a patient through the use of single or multiple intravenous fluid lines and single or multiple intravenous fluid reservoirs wherein a partial section of each reservoir and a partial section of each fluid line are color-coded, and a second portion of each is clear, the fluid lines being clear, colorless and transparent at the injection site.
2. General Background
The administration of liquid medicants and nutrients to patients via intravenous administration is a well established medical practice. Typically, the nutrient or medicant solution is delivered into the patient's bloodstream directly from an intravenous fluid line. Intravenous fluid lines generally consist of a flexible plastic tubing. In a typical intravenous fluid administration system, the intravenous fluid line connects directly with the source of the intravenous fluid. The fluid source is commonly an elevated intravenous fluid storage container that can be of flexible wall plastic construction, for example. In such a typical system, the flow of intravenous fluid to the patient is gravity driven. However, the intravenous fluid may also be pumped into the patient. Many such intravenous fluid pumps are patented.
It is not uncommon for a plurality of intravenous fluid lines, each connected to a different source of intravenous fluid, to simultaneously be used to deliver intravenous fluid therapy to a single patient. The simultaneous use of several different intravenous fluid lines (e.g., 9-10), each connected to a different source of intravenous fluid, is not uncommon in modern medical practice.
The simultaneous use of multiple intravenous fluid lines has led to some major problems in the current art of intravenous fluid administration, including problems with tubing course and rapid identification between multiple tubes. Further, the advances that have been made toward solving these problems have been severely limited by an inability to match utility with quality control.
One major disadvantage of current systems lies in the use of tubing to convey fluids from storage container to patient that is clear and transparent. Transparent clear tubing makes it difficult to monitor the course of the tube whether a single tube is in use or a plurality of tubes. This problem can lead to potentially dangerous disruptions in fluid flow resulting from kinks, tangles, or the like in the intravenous tubing. Such kinks create physical breaks in the continuity of the fluid communication between the patient's bloodstream and the source of the intravenous fluid.
Another significant disadvantage of current systems lies in the ability to easily distinguish between multiple intravenous fluid tubings. The clear and transparent nature of most intravenous fluid tubings makes it difficult to distinguish one line from the other in both routine care and in times of emergency treatment. This problem can become quite dangerous where confusion between different lines could lead to a mixing of incompatible medicants. For example, in the emergency treatment of a heart attack victim bearing several existing intravenous lines, the inability to quickly distinguish between a saline-infusing line and idocaine-infusing line into which to inject TPA could lead to severe consequences as the medicant TPA is incompatible with idocaine if injected into the same intravenous fluid line.
Some recent improvements in intravenous fluid administration technology have helped to ease some of the problems of current systems by easing the identification of multiple fluid lines. However, these improvements in ease of identification have come at the expense of ease of quality control.
Where the problem of rapid identification between multiple intravenous tubes and intravenous fluid reservoirs has been addressed, the result has been to place indicia throughout the entirety of either or both the intravenous tube and the intravenous fluid container. This use of indicia comes at the expense of ease of quality control, in that the indicia blocks or impairs the medical care provider's view of the course of the intravenous fluid administration.
Quality control is a necessary and vital component of the administration of intravenous fluids. Two critical means in which the health care provider monitors the quality of the intravenous fluid administration are to visually examine the fluid in the intravenous fluid container, and the fluid in the intravenous tubings as it enters the patient's body. By casually monitoring the course of the infusion, the medical care provider can be certain that the quality of the intravenous fluid is satisfactory and that the process of the administration is progressing satisfactorily. For example, visual monitoring of the intravenous tubing near the injection site can detect the backing of blood into the intravenous tubing, an indication of a troubled intravenous fluid administration. Also, for example, visual monitoring of the intravenous fluid reservoir can check for clarity of the fluid, the presence of contaminants, precipitation and so forth.
Hence, an unobstructed view of the fluid in both the intravenous tubing near the patient's body and in the intravenous fluid reservoir is critical to proper quality control in intravenous fluid administration. Any intravenous fluid administration that uses indicia which block an unobstructed view of the intravenous fluid at either or both the intravenous tubing near the patient's body and/or the intravenous fluid container suffers from a defect in quality control.
Only the instant invention both overcomes the problems associated with rapidly identifying and distinguishing between multiple intravenous tubings, and provides for a clear, unobstructed view of the intravenous fluid in both the intravenous tubing adjacent the injection site on the patient and in the intravenous fluid reservoir. Hence, only the instant invention both provides for rapid visual distinction between multiple IV tubes and provides ease of quality control.
Prior to the instant invention, other attempts to ease tube identification have come at the expense of quality control. For example, Lappas U.S. Pat. No. 5,224,932 discloses a system for intravenous administration of at least two different liquids to a patient where the tubing is of a translucent color throughout its entirety and where the fluid reservoir is of a translucent color throughout its entirety. Lappas clearly states that at least two distinct liquids are necessary. Further, Lappas does not disclose tubing with a clear section near the patient's body. The invention disclosed in Lappas is colored throughout its entirety. If the section of the tubing adjacent the patient's body is red, a nurse might not be able to see if blood had backed into that flowline.
Another important distinction between the instant invention and Lappas is that Lappas discloses the use of translucent-not transparent-tubing. The instant invention discloses the use of transparent-not translucent-tubing through its entirety. Both where the tubing is colored and where it is clear, the tubing in the instant invention remains transparent. Further, the injection port, base of the drip chamber and the adapter at the patient's body are transparent (clear and colorless)-not translucent-in the instant invention. This transparency is important in allowing for quality control monitoring throughout the course of the instant invention. For example, in the present invention, even in the colored portion of the tubing, a health care provider could visually monitor the fluid for both flow and the presence of particulate matter.
Emanuel PCT patent application WO 91/06255 discloses the use of colored tubing in the intravenous administration of a solution to a patient. A literal reading of the application would indicate that the color-coding is intended to encompass the entirety of the tubing. Further, the Emanuel patent application discloses colored or tinted drip chamber bases and adapters at the patient's body. The drip chamber and adapter at the patient's body in the present invention are clear, colorless and transparent. Thus, the Emanuel patent application does not disclose a clear section of tubing next to the patient's body nor does it address the use of a clear and transparent fluid reservoir that is only partially color coded, leaving a portion clear and colorless.
Kuehlein U.S. Pat. No. 4,557,959 discloses a multilayer working means for containing or transporting a physiological material wherein said working means contain additive agents which absorb radiation in the wave length range of visible light. However, the '959 patent is not addressed at color-coding IV tubing for purposes of identification. Further, a literal reading of the patent indicates that the coloring agent is to be distributed throughout the entirety of the tubing. Therefore, the Kuehlein patent does not disclose a clear section of tubing near the patient's body nor does it disclose anything about the color of an IV fluid reservoir.
Therefore, while the Lappas and Kuehlein patents, and the Emanuel patent application may disclose continuously colored tubing, they do not disclose colored tubing with clear sections, or clear IV fluid reservoirs for quality control.
Underwood U.S. Pat. No. 4,654,026 discusses the use of printed indicia along the tubing which is staggered.
Feldstein U.S. Pat. No. 4,795,429 uses colored tape or other indicia to stick on to transparent tubes.
Smith U.S. Pat. No. 4,892,524 discloses a metering device to control delivery volume. No mention is made of IV tube color or how to solve the problem of identifying the tube's course.
Howes U.S. Pat. No. 4,072,146 discloses a veni-puncture device and a venous catheter device. No application is made to IV tubing.
Watt U.S. Pat. No. 4,150,673 discloses only a colored-coded mating connector.
Baucom U.S. Pat. No. 3,698,383 discloses a device related to minimizing errors in blood handling procedures and blood transfusions. While the patent does address the use of removable indicia stuck to transfusion bags for purposes of identification, the patent does not address IV tubing, problems associated with identifying multiple IV tubing lines, and the use of color as an indica.
Bellamy U.S. Pat. No. 2,896,619 addresses the use of blood type identifying indicia on blood-containing IV bags. However, the patent does not address color-coding, IV tubing, or the problem of identifying multiple IV tubings.
Potolsky U.S. Pat. No. 4,619,640 does not address IV tubing. The patent discloses only the use of an opaquely colored connector.
Noiles U.S. Pat. No. 3,807,397 discloses only a flow meter for measuring the rate of flow of parenteral fluid traveling through a transparent tube. No mention is made of color-coding or to tubing identification.
Smith U.S. Pat. No. 2,954,028 discloses an apparatus for administering parenteral fluids to a patient. However, it does not address the use of color-coding with this apparatus.
Tussing U.S. Pat. No. 1,876,181 discloses a "display package of index guides" which essentially deals with the use of index cards. This invention has nothing to do with IV fluid administration.
Therefore, existing systems do not disclose an IV system wherein, while the tubing is color-coded to ease in identification of single or multiple IV lines, both the fluid reservoir and the section of the IV line near the patient's body are clear to allow for quality control in the transfusion process.